跳至主要内容
临床试验/NCT03862755
NCT03862755已完成4 期

Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism

Shen Lei1 个研究点 分布在 1 个国家目标入组 581 人开始时间: 2017年8月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
581
试验地点
1
主要终点
Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.

研究概览

简要总结

Pulmonary embolism (PE) can be a devastating postoperative complication and the leading cause of mortality after thoracic surgery. PE together with deep venous thrombosis (DVT) is called venous thromboembolism (VTE), whereas PE caused much more serious situation than DVT. Huge amount of data have demonstrated that thromboprophylaxis after surgery is very important to prevent postoperative VTE, especially after orthopedic surgery and plaster surgery. Moreover, for thoracic surgery, American College of Chest Physicians (ACCP) has published prevention guidelines of VTE in non-orthopedic surgical patients and has been used widely, but unfortunately prophylaxis measures had often been underused in China. However, to be honest, there could be a big difference between Chinese and western populations, for example, what guidelines recommended thrombolysis therapy in diagnosed massive or sub-massive PE patients is tissue type plasminogen activator (t-PA) 100 mg, while in China 50 mg has the same effect. So investigators wanted to establish if the prophylaxis measures what they were using currently are suitable for Chinese thoracic surgical patients.

详细描述

Investigators enrolled 598 patients who were sent to thoracic postoperative intensive care unit (ICU) ward right after surgery from August 8 to September 12 of 2017 and those patients stayed in ICU for at least 24 hours. Excluded non-lung surgery there were 581 lung surgery cases. Investigators adopted the Caprini VTE risk assessment model from Boston Medical Center (BMC) in United States of America (USA). According to different risk level, participants received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9). Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. Thromboprophylaxis contraindication included chest tube drainage more than 500 ml or major bleeding during operation or surgeons refusing to use thromboprophylaxis because they thought that patients would benefit more from not performing early ambulation or chemoprophylaxis. Some patients received chemoprophylaxis after they moved back to regular ward out of ICU which was called late chemoprophylaxis which means more than 24 hours after surgery. All chemoprophylaxis were used only during hospitalization. When participants were discharged, no extended treatment prescribed. However, they were followed up twice on 30 days and 60 days after surgery by phone call.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lung surgical patients who were sent to thoracic postoperative intensive care unit (ICU) ward right after surgery and stayed in ICU for at least 24 hours.

排除标准

  • Cases received inferior vena filter and anti-coagulation treatment history.

研究组 & 干预措施

Thromboprophylaxis

Experimental

All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.

干预措施: Chemoprophylaxis with Low Molecular Weight Heparin (LMWH) (Drug)

结局指标

主要结局

Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.

时间窗: up to 8 weeks post operation

Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE.

次要结局

  • Provider Adherence in Implementation of PE Prevention Strategies.(Through study completion, an average of 1 month)

研究者

发起方
Shen Lei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shen Lei

Clinical Associated Professor

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

Loading locations...

相似试验

Chemoprophylaxis Plus Early Ambulation | 临床试验